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Surgical Treatment of Lower Eyelid Involutional Entropion and Dermatochalasis

Primary Purpose

Eyelid Diseases

Status
Unknown status
Phase
Not Applicable
Locations
United Arab Emirates
Study Type
Interventional
Intervention
lower eyelid blepharoplasty , retractor plication and wedge resection
lower eyelid blepharoplasty and retractor plication
Sponsored by
Benha University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eyelid Diseases focused on measuring entropion, blepharoplasty

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Lower eyelid involutional entropion
  2. dermatochalasis

Exclusion Criteria:

  1. Other eyelid disease,
  2. Other causes of entropion
  3. Previous eyelid surgery

Sites / Locations

  • INMCRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

triple procedure

combined procedure

Arm Description

lower eyelid retractors plication , transcutaneous blepharoplasty and wedge resection

lower eyelid retractors plication and transcutaneous blepharoplasty

Outcomes

Primary Outcome Measures

Global Aesthetic Improvement Scale
calculate scale score (1-5); score 1 is exceptional improvement , score 5 is worsened patient

Secondary Outcome Measures

Full Information

First Posted
January 18, 2021
Last Updated
January 26, 2021
Sponsor
Benha University
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1. Study Identification

Unique Protocol Identification Number
NCT04720586
Brief Title
Surgical Treatment of Lower Eyelid Involutional Entropion and Dermatochalasis
Official Title
Lower Eyelid Retractors Plication , Transcutaneous Blepharoplasty and Wedge Resection for Treatment of Lower Eyelid Involutional Entropion and Dermatochalasis
Study Type
Interventional

2. Study Status

Record Verification Date
January 2021
Overall Recruitment Status
Unknown status
Study Start Date
August 1, 2020 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
August 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Benha University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
lower eyelid involutional entropion and dermatochalasis are common associated problems. combined approaches give good results.
Detailed Description
traditional lower eyelid transcutaneous blepharoplasty ; subciliary incision followed by proper dissection then lower eyelid retractors plication after orbital fat removal . pentagon wedge resection of lateral lower eyelid is done

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eyelid Diseases
Keywords
entropion, blepharoplasty

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
triple procedure
Arm Type
Experimental
Arm Description
lower eyelid retractors plication , transcutaneous blepharoplasty and wedge resection
Arm Title
combined procedure
Arm Type
Active Comparator
Arm Description
lower eyelid retractors plication and transcutaneous blepharoplasty
Intervention Type
Procedure
Intervention Name(s)
lower eyelid blepharoplasty , retractor plication and wedge resection
Intervention Description
combined lower eyelid blepharoplasty , retractor plication and wedge resection
Intervention Type
Procedure
Intervention Name(s)
lower eyelid blepharoplasty and retractor plication
Intervention Description
combined lower eyelid blepharoplasty and retractor plication procedures
Primary Outcome Measure Information:
Title
Global Aesthetic Improvement Scale
Description
calculate scale score (1-5); score 1 is exceptional improvement , score 5 is worsened patient
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Lower eyelid involutional entropion dermatochalasis Exclusion Criteria: Other eyelid disease, Other causes of entropion Previous eyelid surgery
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Tarek R Elhamaky, MD
Phone
+971503207889
Email
dr_thamakyy@yahoo.com
First Name & Middle Initial & Last Name or Official Title & Degree
Treak R Elhamaky, MD
Phone
+971503207889
Email
dr_thamakyy@yahoo.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tarek R Elahamky, MD
Organizational Affiliation
Benaha university faculty of medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
INMC
City
Abu Dhabi
ZIP/Postal Code
46266
Country
United Arab Emirates
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TAREK R ELHAMAKY, MD

12. IPD Sharing Statement

Learn more about this trial

Surgical Treatment of Lower Eyelid Involutional Entropion and Dermatochalasis

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